MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN915182

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

It was reported that a clip got broken in two at the hinge at ligation during a robot-assisted rectal resection.The fragments of the broken clip fell, but all of them were withdrawn so no fragment remained in the patient.The operation was completed by the other 5 clips.It is unknown what vessel was being ligated.The medical device used with da vinci surgical system endowrist instrument.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73j2200504 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4) the customer returned two broken clip halves, one hook half and one pierced boss, from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed that the broken clip was broken in half at the hinge.Evidence of use in the form of biological material was observed on the returned sample.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73j2200504 investigation did not show issues related to the complaint.The ifu for this product, l02425 rev.02, was reviewed as a part of this complaint investigation.The returned broken clips were broken at the hinge during loading.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.The reported complaint of broken/detached parts - clip - hinge was confirmed based upon the sample received.One broken clip returned, and were broken in half at the hinge.The clip breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area on the pierce leg side of the hinge.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that a clip got broken in two at the hinge at ligation during a robot-assisted rectal resection.The fragments of the broken clip fell, but all of them were withdrawn so no fragment remained in the patient.The operation was completed by the other 5 clips.It is unknown what vessel was being ligated.The medical device used with da vinci surgical system endowrist instrument.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16119286
• MDR Text Key: 306909010
• Report Number: 3003898360-2023-00061
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73J2200504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/08/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED